Continuous Versus Cyclic Use of Oral Contraceptive Pills in Adolescents

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by The Hospital for Sick Children.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by:
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00326404
First received: May 12, 2006
Last updated: July 17, 2008
Last verified: July 2008
  Purpose

The primary purpose of this study is to compare the compliance rates of adolescents who take oral contraceptives (OCPs) continuously to those who take OCPs cyclically.


Condition Intervention Phase
Contraception
Drug: Desogestrel-Ethinyl Estradiol 21 tablets
Drug: Desogestrel-Ethinyl Estradiol 28 tablets
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Continuous Versus Cyclic Use of an Oral Contraceptive Pills in Adolescents

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • The primary objective is to compare the compliance rates of adolescents who take OCPs continuously to those who take OCPs cyclically. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The number of girls who have positive pregnancy test results at 12 months [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: May 2006
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Desogestrel-Ethinyl Estradiol 21 tablets
The participants in the continuous study arm will be given 4 packs of Marvelon-21, so that they can take the pills continuously for 84 days followed by no medication for 7 days. During these 7 days, the participant will have a withdrawal bleed. This sequence is repeated by the participant for a total of 12 months. Each patient in the continuous arm will have 4 withdrawal bleeds per year.
Other Name: Marvelon-21
Active Comparator: 2 Drug: Desogestrel-Ethinyl Estradiol 28 tablets
The participants in the cyclical arm of the study will be given 3 packs of Marvelon-28 and asked to take all the pills in the packet, including the placebo pills. During the week of placebo pills, these participants will have a withdrawal bleed. Each patient in the cyclical arm will have 12 withdrawal bleeds per year. The duration of study drug treatment for both arms is 12 months.
Other Name: Marvelon-28

Detailed Description:

Oral contraceptive pills have traditionally been prescribed in a cyclical manner, where there are 21-24 days of active pills and 4-7 days of placebo pills or a pill-free interval, creating a 28-day cycle. It has now been proven that as long as a woman has both estrogen and progesterone, her uterine lining is protected and is thin. To that effect, a new OCP (Seasonale®, Barr Laboratories, Pomona, NY) has been packaged in the United States that combines 84 days of active pills with 7 days of placebo pills. This allows a withdrawal bleed every 3 months.

Like in adult women, OCPs are the most popular form of birth control and cycle control in adolescents. But, for a variety of reasons, adolescents tend to have poorer compliance when taking OCPs. Adult women tend to be noncompliant about 6% of the time, but, by the end of one year, adolescents have a non-compliance rate of 34-66%.

There have been few studies that even describe improved compliance and decreased ovarian follicular development in women who take OCPs continuously, which could be beneficial in decreasing the rate of adolescent pregnancy. The majority of the studies looking at continuous use of OCPs have been performed in adult women. At present, there has been only one article that has addressed the use of continuous OCPs in adolescents. Sucato and Gold discussed the indications of continuous use of OCPs, how to prescribe them, and what type of progestin to use; but they did not specifically examine compliance or the safety and efficacy of continuous OCPs in adolescents. We plan to evaluate these issues in our study.

  Eligibility

Ages Eligible for Study:   15 Years to 18 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female
  • Age 15 to 18
  • Presenting to the Gynecology and Adolescent Medicine Clinic for contraception

Exclusion Criteria:

  • Prior use of the study medication with no improvement in symptoms
  • Any medical condition that indicates continuous OCPs (i.e. acute menorrhagia, dysmenorrhea that did not previously respond to cyclical OCP use)
  • Personal history of or current thromboembolic disorder
  • First-degree relative(s) with thromboembolic disorder
  • Cerebrovascular disease
  • Coronary artery disease
  • Cardiac valvular disease
  • Hypertension (systolic blood pressure > 160 mmHg or diastolic > 100 mmHG)
  • Diabetes with retinopathy/neuromyopathy/nephropathy)
  • Breast cancer
  • Endometrial cancer
  • Undiagnosed abnormal uterine bleeding
  • Cholestatic jaundice of pregnancy
  • Hepatic tumor
  • Known or suspected pregnancy
  • Less than 6 months postpartum if breastfeeding
  • Classic migraine with aura or any other neurological signs
  • Gallbladder disease
  • Taking any medications known to affect the efficacy of OCPs (i.e. phenytoin, phenobarbital, primidone, carbamazepine, griseofulvin, rifampin)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00326404

Contacts
Contact: Lisa Allen, MD 416-813-6188 lisa.allen@sickkids.ca

Locations
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Lisa Allen, MD    416 813 6188    lisa.allen@sickkids.ca   
Principal Investigator: Lisa Allen, MD         
Principal Investigator: Sari Kives, MD         
Sub-Investigator: Rachel Spitzer, MD         
Sub-Investigator: Karen Leslie, MD         
Sponsors and Collaborators
The Hospital for Sick Children
The Physicians' Services Incorporated Foundation
Investigators
Principal Investigator: Lisa Allen, MD The Hospital for Sick Children, Toronto Canada
  More Information

No publications provided by The Hospital for Sick Children

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lisa Allen/Principal Investigator, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00326404     History of Changes
Other Study ID Numbers: 1000008437
Study First Received: May 12, 2006
Last Updated: July 17, 2008
Health Authority: Canada: Health Canada

Keywords provided by The Hospital for Sick Children:
Oral Contraceptives
Adolescents
Compliance

Additional relevant MeSH terms:
Contraceptives, Oral
Desogestrel
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Estradiol valerate
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Contraceptive Agents
Contraceptives, Oral, Combined
Contraceptive Agents, Female
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptives, Oral, Synthetic
Progestins

ClinicalTrials.gov processed this record on October 19, 2014